function checks for the tests they are performing." We are unable to determine if the documentation is complete as there is no information submitted about which testing personnel were performing testing on which instrument(s).
Because the laboratory has not shown that it has corrected this deficient practice, we are also unable to determine whether the laboratory's quality assessment mechanisms can monitor the laboratory's corrective actions and ensure this deficient practice does not recur.
The laboratory failed to adequately address this deficiency and provide acceptable evidence of correction consisting of the required documentation and information set forth above and in our January 25, 2016 letter.
D6168
The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
See our review of 06170 and 06171.
D6170
The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
Ex. J, Tab 46 contains lists of patient specimen accession numbers for which the laboratory intended to issue corrected test reports. The laboratory provided no documentation to indicate corrected reports were generated and issued. The submission further states:
- "Based on comprehensive review, multiple examples of failed QC [quality control] without the appropriate documentation with no investigation or corrective action was identified which is now addressed with revised SOPS and training."
- " . . .the review identified multiple examples where technical service provided PM and that service was not documented in addition to failed QC run as part of the service which is now addressed with revised SOPs and training."
The laboratory provided no documentation of investigation or corrective action for these QC failures and lack of maintenance documentation.
Ex. A, Tab 10, § 5.10 states: "Unlicensed laboratory personnel are responsible for performing the activities listed below, under direct and constant supervision by licensed test personnel, with strict adherence to regulatory requirements. . ."
One of the activities listed at§ 5.10.2 is "operation of. . .moderately complex testing instruments. . ."
CMS confirmed with the California Department of Public Health, Laboratory Field Services that unlicensed laboratory personnel cannot operate moderately complex testing instruments in
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